Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

Diarrhea Clinical Trial

Official title: A Phase 2 Study Evaluating a Proprietary Amino Acid Based Medical Food (Enterade®) in Patients With Quality of Life Limiting Diarrhea Due to Carcinoid Syndrome and Other Neuroendocrine Tumors (NET).

Status Completed

Clinical Trial Summary

Primary Objective:

To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control.

Secondary Objectives:

• To assess subject reported health-related quality of life in subjects before and after compound administration.

• To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day.

• To evaluate changes in serum electrolytes before and after administration of Eenterade®.

• To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period.

• To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period.

• To compare subjective feeling of bloating and flatulence before and after administration of Enterade®.

• To evaluate changes in patient weight before and after administration of Enterade®.

Clinical Trial Description

This prospective, phase 2 study is to assess how Enterade® will affect patient-reported quality of life and intestinal absorption in patients with Carcinoid Syndrome and Neuroendocrine Tumors. The hypothesis is that Enterade® when combined with standard supportive care will improve patient-reported quality of life and help maintain the small bowel's ability to absorb and retain fluids, possibly leading to a reduction in diarrhea frequency.

• This is a non-randomized, supportive-care study.

• Potentially eligible patients will be screened in the University of Kentucky Markey Cancer Center clinics.

• During the screening visit, immediately after signing informed consent, the participant will be given both flavors of enterade® (original vanilla and refreshing orange) to test tolerability and taste.

• Eligible subjects will be given a stool diary and will be asked to document daily stool output (frequency and consistency of stool), use of anti-diarrheal medication and gastrointestinal discomforts (bloating, cramping).

• All lab and screening tests should be completed within 2 weeks prior to registration/initiation of study.

• The study is broken into 3 distinct segments and will apply to all enrolled participants: Baseline observation (Weeks 1-4), Enterade® administration period (4 weeks), Post-Enterade® Period (4 weeks).

• After relapse of diarrhea is documented or the 4 weeks of post-Enterade® observation are completed (whatever happens first), participants will be given the option to restart Enterade® for 1 additional month. ;

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Carcinoid Tumor
• Carcinoid Tumor of GI System
• Diarrhea
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Carcinoid Syndrome
• Neuroendocrine Tumors
• Serotonin Syndrome
• Syndrome

• NCT number: NCT03722511
• Study type: Interventional
• Source: University of Kentucky
• Status: Completed
• Phase: Phase 2
• Start date: December 6, 2018
• Completion date: May 18, 2021